a prospective, randomized clinical trial of prp concepts fibrin bio-matrix in non-healing diabetic foot ulcers

Conditions: Diabetic Foot Ulcers

Summary: a prospective, randomized, controlled, clinical study to establish clinical based evidence of prp concepts fibrin bio-matrix and compare its performance with the usual and customary practice for the treatment of wagner 1 or 2 dfus.

this is a prospective, randomized, single-blind, controlled, multi-center study for subjects undergoing dfu treatment. qualified subjects will be randomized (1:1); test group (prp concepts fibrin bio-matrix) and control group (usual and customary practice). the study will consist of 3 periods: a screening period, an active treatment period, and a follow-up period (if healed). approximately 250 subjects will be enrolled. subjects will be ≥18 years of age with a chronic wagner grade 1 or 2 dfu (greater than 1 month duration). each subject will be enrolled in the active treatment period for up to 12 weeks, or to closure of wound with a confirmatory visit 2 weeks after wound closure, whether such closure occurs at 12 weeks or earlier.

Eligibility criteria:
inclusion criteria: * medicare eligible * a full thickness diabetic foot ulcer with a viable wound bed * diabetes mellitus (type i or ii) that is adequately controlled * the ulcer is greater than 4 weeks duration. * the largest non-healing wound, if multiple wounds are present, or the single wound to be treated (index ulcer) is a wagner 1 or 2 dfu (see appendix for wagner classification) that is located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces but not on the heel). * post-debridement, the ulcer size must be between 0.5 - 20 cm2. * one of the following assessments was completed to confirm pedal circulation: ankle / brachial index is between 0.7 to 1.2; transcutaneous partial pressure oxygen (tcpo2) \> 30 mmhg at the ankle; or toe pressure of \>40mm hg or a doppler waveform consistent with adequate flow in the foot (biphasic or triphasic) * able and willing to provide a voluntary written informed consent. * able and willing to wear an off-loading device or orthopedic shoe * able and willing to attend scheduled follow-up visits and study related exams exclusion criteria: * greater than 30% reduction in wound size during the first two weeks of observation and treatment by the investigator * wagner 3, 4, 5 dfu * gross clinical infection at the study ulcer site including cellulitis and osteomyelitis * wounds that are likely to require dressing changes more frequent than twice weekly (heavy exudates). * known allergy tor sensitivity to eclipse prp kit components (calcium chloride, calcium gluconate or acid citrate dextrose solution a (acda)) * presence of gangrene * active charcot's disease as determined by clinical and radiographic examination of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers) * malignancy at or near the ulcer site * known serum albumin \ 2.5 mg/dl, plasma platelet count of less than 100 x 109/l, hemoglobin of less than 10.5 g/dl * rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, hiv * severe liver disease. severe liver disease is defined as known history of chronic hepatitis or cirrhosis \&/or the following abnormal liver function tests: alt \& ast \>35, alp \>120, pt \>12 seconds. * presence of additional abnormal lab values obtained within 7 days prior to the day 0 visit determined to be clinically significant by the investigator including: wbc \>13,000/cm3 or \< 5, 000 cm3, or electrolytes that are outside the host institution's range of normal. * radiation therapy, chemotherapy, chronic steroid use or immunosuppressive therapy within 30 days of enrollment * received another investigational device or drug within 30 days of enrollment * received allograft, autograft or xenograft within 30 days of enrollment * subject has inadequate venous access for repeated blood draw required for eclipse rpr administrations * subject requires or is anticipated to require interventions directed at improvement of arterial perfusion to affected area. * ulcer expected to be treated with any advanced therapeutics (e.g., hbot) * any condition judged by the investigator that would cause the study to be detrimental to the subject * alcohol or drug abuse, defined as current medical treatment for substance abuse * pregnant or nursing women

Keywords: non-healing wound diabetic foot ulcer platelet rich plasma